FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EML105 ELECTROLYTE METABOLITE ANALYZER
K Number: K962334
·
Decision Oct 24, 1996
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
50
Review Days
129
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Basic Information
- Device Name
- EML105 ELECTROLYTE METABOLITE ANALYZER
- K Number
- K962334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer America, Inc.
- Date Received
- June 17, 1996
- Decision Date
- October 24, 1996
- Product Code
- JGS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | Oct 6, 1997 | Substantially Equivalent |
| K962158 | PICO MODELS 30, 50, 70 | Oct 29, 1996 | Substantially Equivalent |
| K961355 | MULTICHECK | Jun 14, 1996 | Substantially Equivalent |